Testing Methylphenidate for Smoking Abstinence

Once enrolled in study, the subject will be put in one of 2 groups by chance (as in the flip of a coin). They will either receive methylphenidate or a placebo. Everyone in study will receive nicotine dependence counseling based on the intervention manual "Smoke Free and Living It". Everyone will be asked to complete weekly study visits for 8 weeks and one follow-up phone call at week 16 and a final study visit at week 24. The target quit day is the day after visit 4 (week 2 + 1 day). In the first two weeks after starting study medication they will slowly build up to 3 pills a day. For weeks 2 through 8 they will continue to take 3 pills a day.

Inclusion criteria

• Are between 18 to 65 years of age
• Have smoked cigarettes daily for the past 6-months and are currently smoking > 10 cigarettes/day
• Are willing to make an attempt to stop smoking
• Are able to participate fully in all aspects of the study
• Have been provided with, understand, and have signed the informed consent

Exclusion criteria

• Have clinically significant levels of current depression as assessed by CESD and determined by the physician; or have a life-time diagnosis of bipolar disorder, schizophrenia or dementia as determined by physician investigator
• Are currently (in previous 30 days) using any tobacco treatment program (i.e., behavioral therapy, nicotine replacement therapy, bupropion SR, varenicline, clonidine or nortriptyline)
• Have used an investigational drug within the 30 days prior to enrolling in this study
• Alcohol or drug abuse or dependence within the past year as assessed by the study investigators using CAGE questionnaire and the Drug Abuse Screening Test 20 (DAST-20)
• Are pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use contraception. The following birth control measures are acceptable: approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, the use of two combined barrier methods (diaphragm with spermicide or condom with spermicide), birth control pills, injections, intrauterine device [IUD], abstinence, or surgical sterilization of subject or of monogamous partner.
• Have a history of any major cardiovascular event in the past 6-months including unstable angina, acute MI or coronary angioplasty
• Have clinically significant acute or chronic, progressive or unstable neurologic (dementia, delirium or seizure disorder), hepatic, renal, cardiovascular, respiratory or metabolic disease that would limit participation in the study
• Are currently on the following prescribed medications known to interact with methylphenidate and not able to stop the medication during the study period: stimulants, warfarin, anticonvulsants, antidepressants, antipsychotics, monoamine oxidase inhibitors, clonidine, theophylline and pseudo-ephedrine
• Uncontrolled hypertension (>160/100) or tachycardia (Heart rate >110)
• Have another house-hold member or relative participating in the study
• Have known allergy to methylphenidate or its constituents
• Have a specific medical condition where use of methylphenidate is contraindicated: narrow angle glaucoma, motor tics, family history or diagnosis of Tourette's syndrome, and history of GI obstruction (including history of strictures, adhesions, or abdominal surgery)
• have an ECG with significant arrhythmias or abnormal conduction, which in the opinion of the physician investigator preclude participating in the study.